MAUDE Adverse Event Report: DENTSPLY SIRONA ORTHODONTICS INC. NONTEMPLATE ALIGNER ARCH; ALIGNER, SEQUENTIAL

Catalog Number 00856379007023

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 01/23/2024

Event Type  Injury  

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

In this event it is reported that patient experienced allergic reaction, symptoms consisted of swollen tip of tongue, pain in the throat while swallowing and irritation inside the mouth.The symptoms resolved on their own after cease wearing of the aligners for 7-8 days.No additional medical treatment was required.Aligner treatment stopped.

Manufacturer Narrative

Investigation results: photo investigation - in the evidence provided (allergic reaction checklist) the patient declares that he is allergic to pets.- report the following symptoms when using the aligners.- tongue swelling.- he declares that he did not test the patient for reaction to the product.- the photographs provided show the alleged fact, swelling in the patient's tongue.Dhr evaluation: we reviewed the dhr for this so-(b)(6) / patient id# (b)(6)/ practice id# (b)(6) qty.(b)(4) items assy-500011 (aligners), (b)(4) items assy-500010 (template) were packaged by of first shift by bag and box operation on september 18, 2023, manufacturing supercell sc0, equipment bag-15.The sales order was inspected and met with the acceptance criteria provided by qa.Incoming inspection.We reviewed the incoming inspection record for the material used to manufacture this so-(b)(6).· raw material: part-501019 / lot# 231446 / qty.Received = (b)(4) rolls, inspection date: may 17, 2023.· the material was found to be acceptable for use in the manufacture of the sure smile product.Failure mode: allergic reaction root cause: no defect conclusion code: no failure found.

• Brand Name: NONTEMPLATE ALIGNER ARCH
• Type of Device: ALIGNER, SEQUENTIAL
• Manufacturer (Section D): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer (Section G): DENTSPLY SIRONA ORTHODONTICS INC.; 2350 campbell creek blvd. suit; richardson TX 75082
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 18622731
• MDR Text Key: 334322987
• Report Number: 1649995-2024-00003
• Device Sequence Number: 1
• Product Code: NXC
• UDI-Device Identifier: 00856379007023
• UDI-Public: 00856379007023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 00856379007023
• Device Lot Number: 07589121
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/23/2024
• Date Manufacturer Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2023
• Is the Device Single Use?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Female